Managing Drug With IRT

When selecting an IRT (IVR/IWR) system for your clinical trial, what features should it have to ensure you can adequately manage the critical but logistically complicated world of study drug?

Here’s a quick checklist of things to consider:

Ability to have ‘at-a-glance’ access to information relevant to study drug– for example, in a straightforward table view – without the need for complicated querying, and with the ability to deliver or withhold types of information based on user roles. An at-a-glance view should include:

Site

Sequence number (blinded unit randomization)

Study-specific IP unit label – i.e., kit, bottle, vial, etc.

Drug/treatment type - ability to make available only to unblinded users

Shipment in which the unit was included

Batch or lot in which the unit was included

Subject to whom the unit was assigned

Activity/date at which the unit was assigned – including ability to assign at unscheduled visits. Disallow changing assignment dates.

Current unit status – e.g., options should include: assigned, available to be assigned, missing, in transit, unusable, damaged, mis-administered (and to whom/when), quarantined/subjected to temperature excursion